NCT00824317

Brief Summary

The purpose of this study is to compare the response to methylphenidate treatment of children with two different subtypes of ADHD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 16, 2009

Completed
Last Updated

January 16, 2009

Status Verified

January 1, 2009

Enrollment Period

3.3 years

First QC Date

January 15, 2009

Last Update Submit

January 15, 2009

Conditions

ADHD

Outcome Measures

Primary Outcomes (1)

  • (BLIND) CLINICIAN RATING ON ADHD-RS (SYMPTOM CHECKLIST) AND CGI (CLINICAL GLOBAL IMPRESSIONS)

    Weekly

Secondary Outcomes (1)

  • WEEKLY RATINGS BY PARENTS AND TEACHERS ON WELL-NORMED MEASURES OF ADHD SYMPTOMS AND FUNCTIONAL IMPAIRMENT PREVIOUSLY SHOWN TO BE DRUG-SENSITIVE (CONNERS AND SKAMP SCALES).

    Weekly

Study Arms (2)

1

PLACEBO COMPARATOR

Placebo

Drug: Placebo

2

EXPERIMENTAL

methylphenidate

Drug: methylphenidate

Interventions

methylphenidateDRUG

(15 mg daily), medium (25 mg daily) and high (40 mg daily)

2
PlaceboDRUG
1

Eligibility Criteria

Age7 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • A diagnosis on the structured DISC interview conducted with the parent, of ADHD, Predominantly Inattentive Type.
  • Ratings by parent and by teacher corresponding to a total score above the 93rd percentile (i.e. more than 1.5 SD above the mean) on the scale of "DSM-IV Inattention" on the current Conners Parent (or Teacher) Rating Scale - Long Form. The items on this scale are the inattention symptom criteria from the DSM-IV, each of which the informant is asked to rate in severity on a 4-point scale ranging in severity from 0 ("not at all") to 3 ("very much"). A score above the 93th percentile indicates that the child's score equals or exceeds that for 93% of other children of the same age (within 2 years) and gender.

You may not qualify if:

  • (a) Scores more than 1 SD (84th percentile) above the mean on the DSM-IV-Hyperactive-Impulsive scale on the Conners Parent or Teacher Rating Scales-Long Form.
  • Combined Subtype:
  • A diagnosis of ADHD, Combined type on the structured DISC interview with the parent.
  • Ratings by parent and teacher each corresponding to a total score above the 93rd percentile (i.e. more than 1.5 SD above the mean) on the scale of "DSM-IV attention" on the current Conners Parent (Teacher) Rating Scales - Long Form.
  • Ratings by parent and teacher each corresponding to a total score above the 93rd percentile (i.e. more than 1.5 SD above the mean) on the scale of "DSM-IV Hyperactive-Impulsive" symptoms on the current Conners Parent (Teacher) Rating Scales - Long Form.
  • Both Groups:
  • WISC-III full-scale IQ less than 80.
  • Major acute or chronic medical condition, including sensory loss, and neurological disorder, or any medical condition that would preclude the use of stimulant medication.
  • Children with any of the following conditions will be excluded from the study: psychosis, any pervasive developmental disorder, and bipolar disorder. Thus children will be permitted in the study if they have a comorbid learning disability, oppositional defiant disorder, or conduct disorder. The Wechsler Individual Achievement Tests will be administered in order that we can characterize our sample with respect to the presence of comorbid learning disabilities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Mary Solanto

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 15, 2009

First Posted

January 16, 2009

Study Start

October 1, 2001

Primary Completion

February 1, 2005

Study Completion

February 1, 2005

Last Updated

January 16, 2009

Record last verified: 2009-01

Locations

US(1)